Inflatable balloon device and applications

ABSTRACT

A self-propelled device for locomotion through a lumen, comprising a set of serially arranged inflatable chambers, and incorporating a number of novel aspects. To enable easy insertion and use, the rigidity of the device is increased by means of rigid inserts in the balloons, or by use of stiff springs between segments. The working channel can be attached to the distal chamber of the device, such that it is pulled from the leading end of the device during inflation, rather than being pulled from the trailing end of the device during deflation. Lumen wall inspection or treatment facilities are enabled by means of a camera or treatment arm mounted between two distally positioned balloons, the device is able to provide observation capabilities to the lumen wall, yet without becoming excessively dirty by exposure to the front end of the device, as in prior art camera units.

FIELD OF THE INVENTION

The present invention relates to the field of inflatable devices capableof self propelled motion through tubes, especially for endoscopic andvascular use.

BACKGROUND OF THE INVENTION

The ability to crawl through long, flexible, and curved tubes has longbeen a challenge for engineers since numerous applications can benefitfrom a reliable solution. This ranges from medical applications fortreatment and diagnosis to sewer pipes, gas pipes and power plants.

Current solutions often contain a payload such as a camera, that ispushed from the back by a long flexible rod or wire. This is thesolution currently used in most medical applications with guide wires orcatheters as used to deliver diagnosis or treatment instruments to thedesired position, e.g. catheterization, colonoscopy, ureteroscopy,dilating balloon, and others.

In some type of applications it is impossible to push the active headfrom the back because the force required would cause buckling of thelong rod or wire. One of the biggest shortcomings of current endoscopesand catheters is that they are pushed into the human body manually overa curved path, thereby causing friction, and possible injuries to theinner tissue walls of the lumen.

In search for a solution, a number of locomotion types of propulsionhave been developed, which pull at the distal end of the lumen ratherthen pushing at the proximal end. Examples in non-medical applicationsinclude crawling vehicles and spider-like robots, such as are describedin U.S. Pat. Nos. 6,824,510, and 5,090,259. In medical applications themost common solution is that of the inch worm type, that advances bymeans of peristaltic motion, such as is described, for instance, in U.S.Pat. Nos. 6,764,441, 4,176,662, 5,090,259, 5,662,587, 6,007,482 and5,364,353, and in the article by P. Dario, et al., “Development and invitro testing of a miniature robotic system for computer-assistedcolonoscopy,” published in Computer Aided Surgery, Vol. 4, pp. 1-14,1999, and in the article “A Locomotive Mechanism for a RoboticColonoscope” by Byungkyu K, et al., published in Proceedings of theIEEE/RSJ Intl. Conference on Intelligent Robots and Systems; 2003, pp.1373-8. Another type of medical application device is described in U.S.Pat. No. 6,702,735.

Another solution is one which imitates the locomotion of the earth-worm(Annelida), that generates waves of contraction and relaxation ofalternate muscle groups (longitudinal and circular muscles), causing theworm to move forward, such as is described in the article by J. Dietrichet al., entitled “Development of a peristaltically actuated device forthe minimal invasive surgery with a haptic sensor array” published inMicro- and Nanostructures of Biological Systems, Halle, Shaker-Verlag,69-88. ISBN 3-8322-2655-9. Another solution suggested uses motionhydraulically generated close to the tip, such as is described in U.S.Patent Application 2005/0033343, for “Catheter Drive” to I. Chermoni.

Most of the above described devices have the disadvantage that a numberof control lines or pneumatic tubes are required to operate the device,which complicates both the control system and the physical deployment ofthe device within the passageway. The device described in theabove-mentioned U.S. Pat. No. 5,364,353 for “Apparatus for advancing anobject through a body passage” to M. T. Corfitsen et al., and that inco-pending PCT Application No. PCT/IL2006/000925 for “Tip propelleddevice for motion through a passage” to the authors of the presentapplication, on the other hand, require only one inflation tube. In U.S.Pat. No. 5,364,353, there is described a device using a single bladderand an axially expandable bellows with a throttle valve between them. Atube is provided with a lumen for the supply and removal of inflationmedium to the bladder and bellows. The throttling valve ensures that theinflation of the bladder is delayed relative to the axial expansion ofthe bellows as pressure is applied to the inflation tube, and that thedeflation of the bladder is delayed relative to an axial contraction ofthe bellows as pressure is released from the inflation tube, such thatthe device can be advanced stepwise through, for instance, agastrointestinal canal.

In co-pending PCT Application No. PCT/IL2006/000925, there is describeda device having a plurality of inflatable chambers arranged serially,and serially interconnected by means of small orifices, openings ortubes between adjacent chambers, in which at least the first and lastchambers are expandable at least radially, and also optionally axially,and other intermediate chambers, if present, are expandable at leastaxially and also optionally radially. A tube is provided with a lumenfor the supply and removal of inflation medium to the chambers. Thesmall orifices, openings or tubes ensure that the inflation of onechamber relative to that preceding it is delayed, such that the chambersinflate sequentially as fluid is pumped into an inflation tube.Likewise, the deflation of a chamber is delayed relative to that infront of it as pressure is released from the inflation tube, such thatthe device can be advanced stepwise through, for instance, agastrointestinal canal.

Many of the above described devices may have various disadvantages whichlimit their usefulness in one aspect or another, such that there is needfor a new, distally propelled catheter head which can operate simply,over long tracts of internal passages, and without causing undue damageto the inner walls of the passages.

It is to be understood that the terms chamber, balloon, bladder andsimilar expressions used to describe the inflatable components of thevarious devices of the present application, may have been usedinterchangeably and even claimed thuswise, and it is to be understoodthat no difference is intended to be conveyed by use of one term or theother.

The disclosures of each of the publications mentioned in this sectionand in other sections of this application, are hereby incorporated byreference, each in its entirety.

SUMMARY OF THE INVENTION

The present invention seeks to provide new methods and devices for usein serial inflatable balloon self-propulsion devices, for motion alonginternal passageways, having features which are enabling for efficientuse of such devices.

In a first aspect of this invention, embodiments are described wherebythe device is maintained in a sufficiently rigid condition that it doesnot collapse when pushed into the lumen. Rigid balloon inserts orslidable or telescopic extensions to the segments between the balloonsare able to accomplish this. Alternatively and preferably, a spring oran accordion-like trellis array can be attached between adjacentseparators, such that a spatial relationship is maintained betweenadjacent balloons, while allowing some level of flexibility. Flexibilitycan also be imparted to the device by use of semi-flexible segmentsections.

According to other embodiments of the present invention, there aredescribed such devices in which the working channel is attached to thedistal chamber of the device, such that it is pulled from the leadingend of the device during inflation, rather than being pulled from thetrailing end of the device during deflation. This provides more positivemotion for a bigger payload, and better motion control. In suchembodiments, a method is required to enable the fluid supply to beapplied to the trailing sheath when the working channel moves relativeto the trailing sheath in unison with the front balloon to which it isattached. This is done using a closed chamber with a section of curvedworking channel slack disposed therein.

Other aspects of the invention describe embodiments in which thetrailing supply or service lines are carried in a coiled-up manner in achamber carried at the rear of the device, such that it can be deployedrearwardly as the device progresses. Additionally, embodiments aredescribed in which the supply of inflating fluid to either end of theserial array of balloons, enables the device to travel in eitherdirection, depending on which end of the device the fluid is applied to.

A further aspect of the present invention relates to the provision ofviewing or handling facilities to the device. By locating the viewingcamera in between two distally positioned balloons, the device is ableto provide observation capabilities to the lumen wall, yet withoutbecoming excessively dirty by exposure to the front end of the device,as in prior art camera units. Additionally, a robotic biopsy arm oranother treatment device can be easily mounted in the position betweenchambers, and to perform procedures on the lumen wall. Wall washingfacilities are also available in that embodiment.

There is therefore provided in accordance with a preferred embodiment ofthe present invention, a self-propelled device for locomotion through alumen, comprising:

(i) a set of serially arranged inflatable chambers, with a distalchamber at one end of the device, and a proximal chamber at the oppositeend of the device,

(ii) a fluid supply system for inflating the chambers sequentially, suchthat during inflation, the device moves with the distal chamber leading,and

(iii) an axial channel running axially through the device, the channelbeing attached to a distal part of the device.

In such a device, it is the motion of the device through the lumen thatpulls the axial channel with it. The axial channel may preferably beattached to either one of the distal chamber or the chamber immediatelyproximal to the distal chamber.

Furthermore, in accordance with yet another preferred embodiment of thepresent invention, in any of the above-described devices having achannel attached to a distal part of the device, the fluid for inflatingthe chambers may preferably be supplied through a sheath enclosing theaxial channel. Alternatively and preferably, the fluid for inflating thechambers may be supplied through a separate supply tube.

In accordance with yet another preferred embodiment of the presentinvention, in such a device having a sheath around the axial channel,the fluid supply system may preferably comprise a hermetically sealedrigid chamber, the chamber comprising:

(i) an input port for inputting fluid to the rigid chamber,

(ii) an output port for outputting fluid to the sheath for inflating theinflatable chambers, and

(iii) a working channel port to which the proximal end of the axialchannel is attached after traversing the rigid chamber in a path havinga length of slack channel.

In such a case, motion of the distal chamber of the device is operativeto pull the axial channel, such that the length of slack channelshortens.

In the above described devices with an axial channel attached to adistal part of the device, the inflatable chambers may preferably havethe form of an annulus, the axial channel running through the annulusand outside of the inflatable volume of chambers, and wherein the fluidfor inflating the chambers is supplied by a tube separate from the axialchannel. Alternatively and preferably, the axial channel may be adaptedto accommodate functional leads to either one of a viewing system and anoperating tool system carried at the distal end of the device.

There is also provided in accordance with yet a further preferredembodiment of the present invention, a self-propelled device forlocomotion through a lumen, comprising:

(i) a set of serially arranged inflatable chambers having separatorsegments between adjacent chambers,

(ii) a fluid supply system for inflating the chambers sequentially, and

(iii) a stiffening element inserted in at least one of the chambers, thestiffening element essentially filling the length of the at least onechamber when uninflated, such that when the at least one chamber isuninflated, the stiffening element provides the device with axialrigidity between the separator elements associated with the at least onechamber.

The above described device may also preferably comprise an axial memberdisposed axially along the device, wherein the stiffening element slidesalong the axial member as the at least one chamber inflates. Thestiffening element may preferably have a tubular form, and maypreferably be attached to a separator element.

In accordance with still another preferred embodiment of the presentinvention, the stiffening element may preferably comprise twooverlapping elements, each attached to a separator element at oppositeends of a chamber, one of the overlapping elements sliding within theother as the chamber inflates.

There is further provided in accordance with still another preferredembodiment of the present invention, a device as described above, and inwhich the stiffening element may preferably comprise a spring attachedto the separator elements at opposite ends of the at least one chamber,the spring having a closed length which essentially fills the length ofthe at least one chamber when uninflated. Alternatively and preferably,the stiffening element may preferably comprise an expandable cylindricaltrellis structure attached to the separator elements at opposite ends ofthe at least one chamber, the trellis structure having a closed lengthwhich essentially fills the length of the at least one chamber whenuninflated.

According to another aspect of the invention, in the above describeddevice, the at least one chamber may preferably have an annular form,the device further comprising a central axial member running through thecenter of the annular chamber.

There is further provided in accordance with still another preferredembodiment of the present invention, a self-propelled device forlocomotion through a lumen, comprising:

(i) a set of serially arranged inflatable chambers having separatorsegments between adjacent chambers, and

(ii) a fluid supply system for inflating the chambers sequentially,

wherein at least one of the separator segments is flexible, such thatthat part of the device in the vicinity of the at least one separatorsegment can negotiate a bend in the lumen by flexing of the at least oneseparator segment. In such a device, the at least one flexible separatorsegment may preferably have an interior that is inflatable, such thatthe flexibility of the segment can be controlled in accordance with theinflation pressure of the segment.

In accordance with a further preferred embodiment of the presentinvention, there is also provided a self-propelled device for locomotionthrough a lumen, comprising: (i) a set of serially arranged inflatablechambers, (ii) a fluid supply line for inflating the chamberssequentially, and (iii) a container carried by the proximal one of theinflatable chambers, the container comprising a compacted portion of thefluid supply line, such that as the device traverses the lumen, thefluid supply line deploys from the container. In such a device, thecompacted portion of the fluid supply line may preferably be a coiledportion.

There is even further provided in accordance with another preferredembodiment of the present invention, a self-propelled device forlocomotion through a lumen, comprising:

(i) a set of serially arranged inflatable chambers, having at least adistal and a proximal chamber, and

(ii) a fluid supply system for inflating the chambers sequentially,

wherein the fluid supply system may preferably be connectable to theproximal chamber and to the distal chamber, such that the device canmove in either direction in accordance with which of the chambers issupplied with fluid. In such a device, the fluid supply system maypreferably be connectable to the proximal and distal chambers either byseparate supply lines, or by a single supply line directed to one or theother of the proximal and distal chambers by means of a valve.

Furthermore, in accordance with yet another preferred embodiment of thepresent invention, there is also provided a self-propelled device forlocomotion through a lumen, comprising:

(i) two sets of serially arranged inflatable chambers, each having leasta distal and a proximal chamber, the sets being connected serially, and

(ii) a fluid supply system for inflating the chambers of each of thesets sequentially,

wherein the fluid supply system is connectable to a proximal chamber ofone set and to a distal chamber of the other set, such that the devicecan move in either direction in accordance with which of the chambers issupplied with fluid. In such a device, the fluid supply system maypreferably be connectable to the proximal and distal chambers either byseparate supply lines, or by a single supply line directed to one or theother of the proximal and distal chambers by means of a valve.

There is also provided in accordance with a further preferred embodimentof the present invention, a self-propelled device for locomotion througha lumen, comprising:

(i) a set of serially arranged inflatable chambers,

(ii) a fluid supply system for inflating the chambers sequentially, and

(iii) a flexible tubular membrane enclosing at least one pair ofadjacent chambers, the membrane having at least one orifice disposed inthe region between the at least one pair of chambers.

This device is preferably such that when the at least one pair ofchambers are inflated, the pressure within the flexible membrane fallsand any collapsible part of the lumen is pulled onto the membrane,sealing the orifice.

In accordance with yet another preferred embodiment of the presentinvention, there is also provided a self-propelled device for locomotionthrough a lumen, comprising:

(i) a set of serially arranged inflatable chambers,

(ii) a fluid supply system for inflating the chambers sequentially, and

(iii) an operating pod disposed between the distal one of the chambersand the chamber immediately proximal thereto.

The operating pod may preferably contain either or both of a viewingdevice directed at the lumen wall, and a surgical tool disposed suchthat it can perform a surgical procedure on the lumen wall.

Finally, in accordance with still another preferred embodiment of thepresent invention, there is provided a self-propelled device forlocomotion through a lumen, comprising:

(i) a set of serially arranged inflatable chambers,

(ii) a fluid supply system for inflating the chambers sequentially, and

(iii) an operating pod disposed either between a pair of the chambers orat the distal tip of the device, the pod comprising a system forcleaning the inside surface of the lumen as the device proceedstherethrough.

In such a device, the cleaning system may preferably be supplied withcleaning fluid by a supply line running through the device.Additionally, the cleaning system may further comprise a flushing linefor removing debris cleaned from the lumen wall by the cleaning system.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be understood and appreciated more fully fromthe following detailed description, taken in conjunction with thedrawings in which:

FIG. 1 illustrates schematically a tip-propelled catheter device,constructed and operative according to a first preferred embodiment ofthe present invention;

FIGS. 2A to 2I illustrates schematically how the fluid inflates theballoon cells of the device of FIG. 1 in a sequence that causes thedevice to move forward;

FIGS. 3A to 3C illustrate embodiments of the present invention toovercome potential difficulty in inserting an inflatable balloon deviceinto a lumen to be negotiated, and in enabling it the device to progressfreely once inserted;

FIGS. 4A and 4B illustrate more preferred embodiments for providingaxial stiffness to an inflatable balloon device;

FIGS. 5A-5C illustrate another preferred embodiment in which axialstability is guaranteed by a flexible spring inserts operating inaccordion fashion;

FIGS. 6A-6B illustrate another preferred embodiment similar to that ofFIGS. 5A-5C, but using an extendible trellis structure;

FIGS. 7A and 7B illustrate more preferred embodiments for providingaxial stiffness to an inflatable balloon device, using separatorelements with extended inter-sliding end extensions;

FIGS. 8A-8B illustrate another preferred embodiment for providing axialstiffness to an inflatable balloon device, using floating rings withinthe balloons;

FIGS. 9A-9G illustrate another preferred embodiment of an inflatableballoon device, in which the working channel is attached to the tip ofthe device to provide improved traction;

FIGS. 10A-10G illustrate another preferred embodiment similar to that ofFIGS. 9A-9G, but using annular balloons;

FIGS. 11A and 11B illustrate a termination chamber compensating for thedifferent changes in length of the working channel and the supply linein the embodiments of FIGS. 9A-9G and 10A-10G as the device progresses;

FIGS. 12A-12C illustrate embodiments which allow the inflatable balloondevice to bend by providing flexible separator sections betweenballoons;

FIGS. 13A and 13B illustrate another preferred embodiment of the presentinvention, in which the supply line and/or working channel are deployedrearwards during propulsion;

FIGS. 14A and 14B illustrate another preferred embodiment of the presentinvention, which enables the device to travel backwards out of thelumen, as well as forwards into the lumen;

FIGS. 15 and FIGS. 16A and 16B illustrate alternative embodiments ofdevices which can be propelled in both directions.

FIGS. 17A-17D, FIGS. 18A-18D and FIGS. 19A-19D illustrate alternativemethods of manufacturing balloons for use in the devices of the presentinvention;

FIGS. 20A-20D illustrate another preferred embodiment of the presentinvention, which enables the device to propagate in a flexible,slippery, collapsible media, such as a colon, by maintaining firmcontact between the balloons and the lumen wall;

FIGS. 21A and 21B illustrate another preferred embodiment of the presentinvention, which enables the device to view the lumen inner wall using acamera built into an inter-balloon compartment, to clean the wall beingviewed, and to perform surgical procedures on the wall; and

FIG. 22 illustrates another preferred embodiment of the presentinvention for providing a wall cleaning ability to the instrument.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Reference is now made to FIG. 1, which illustrates schematically atip-propelled catheter device 15 for traveling down a lumen 1, as isknown in the art. The device may preferably comprise a number ofballoons 11 connected to each other by separators 12 with one or moresmall openings, preferably in the form of orifices 13 formed therein,such that all the balloons comprise a single volume, inflatable througha single input. For ease of construction, the device can alternativelyand preferably comprise a single inflatable balloon divided intoseparate balloon segments by separators with orifices such that theentire segmented balloon can be inflated through a single input. Theballoon fabric is preferably held in place relative to the separators 12by means of rings 17 or glued or molded to the separators. Whicheverpreferred construction is used, the device is connected by a single tube16 to a fluid supply for inflating the balloons or the balloon segments.For the sake of simplicity, the operation of the device will beexplained using the term balloon for each separate segment, although itis to be understood that the invention can equally be implemented usinga single balloon segmented to form the separate segments. The inflationfluid used can be any one of a compatible gas or liquid. The fluidsupply can alternatively be taken from the passageway through which thedevice is moving, by means of an on-board pump, and ejected theretoafter use.

Reference is now made to FIGS. 2A to 2I which illustrates schematicallyhow the fluid inflates the balloon cells in a sequence that causes theproximal one to inflate first, increasing its diameter as well as itslength. Being inflated, it locks itself against the inside walls of thetube, but at the same time, its increase in length advances the othercells which are not fully inflated yet and hence are not locked on theinside walls of the tubes. The cells are inflated in a sequence untilthe distal cell locks against the inner tube walls, but at a positionfurther along the tube than that of the un-inflated balloon distal cellinitial position. This situation is reached in FIG. 2E. The timing andorder of the sequence is mandated by the fluid flow dynamics through theorifices, and the dynamics of the balloon inflation. Disconnecting thesupply and allowing the fluid pressure to drop at this point, or pumpingout the fluid, as shown in FIG. 2F, causes the proximal cell to deflatefirst reducing both its length and diameter. Since the distal cell andall of the intermediary cells, are at this point still fully inflated,they are still locked against the inner walls of the tube, thus pullingthe proximal cell inward as the balloon deflates and decreases itslength.

The sequential motion series is repeated inducing motion of the entiredevice as can be seen in FIGS. 2A to 2I. The locomotion sequence iscomposed of two phases: inflation and deflation, with the arrows at theentrance of the inflation tube indicating the direction of fluid flow. Asimplified description of the dynamics of the sequential inflation is asfollows:

The flow through an orifice is proportional to the square root ofpressure difference across the orifice, and the square of the diameterof the orifice, such that the orifice sizes can be selected to providespecific inflation dynamics.

Inflation phase: Initially, the pressure is equal in each balloon and isequal to the outside pressure, therefore the balloons are in deflatedcondition, as in FIG. 2A. When the pressure in the supply tube rises,the fluid begins to flow through the first orifice into the first(proximal) balloon, as in FIG. 2B. The pressure difference between thefirst and second balloons is now lower than the pressure differencebetween the supply tube and the first balloon, such that the flow ratein the second orifice is slower and the second balloon inflates moreslowly than the first one. By this means, the pressure propagates in agradual manner to the last (distal) balloon until the pressure in allthe balloons is equal, as shown in FIG. 2E.

Deflation phase: Now the pressure in the supply tube is reduced to theoutside pressure, or the fluid is pumped out of the inflation tube, andthere is then a pressure drop between the supply line and the firstballoon. The fluid begins to flow out of the first balloon, as in FIG.2F. Again, since the pressure difference between the supply tube and thefirst balloon is greater than between the rest of the balloons, thefirst balloon deflates first, then deflates the second, and so on untilthe last balloon is deflated, as in FIG. 2I.

In a variation of the actuation sequence, it is possible to initiate thecycling process even before the last cell is fully deflated. In such acase there will always be a base point anchored to the passageway andhence will prevent unwanted slippage in the case of external forces.Different orifices sizes, or different numbers of orifices, can be usedbetween different positioned balloons to improve the locomotion andspeed of the device, all according to the dynamics of the fluid flow into, out of, and between balloons. Furthermore, the viscosity of theinflation fluid can be chosen to improve the locomotion dynamics.

In some applications of the devices shown in FIGS. 1 and FIGS. 2A-2I andin many of the other embodiments described in co-pending InternationalApplication No. PCT/Il2006/000925, and such as are described in otherdocuments describing serial inflatable balloon devices, there may bedifficulty in inserting the device into the lumen to be negotiated, andthere may also be difficulty in enabling it to progress freely onceinserted.

The insertion problem may arise if the device has a structure which isso flexible that there may be some difficulty inserting it into the bodyor the pipe by pushing. It may then be desirable to increase the axialstiffness, to facilitate entry by pushing, but preferably withoutaltering the propulsion capabilities.

The propagation problem may arise if the proximal inflating balloonstend to compress the array of distal balloons, rather than pushing themand their payload forward. This problem may be exacerbated in thepresence of the first problem of lack of axial stiffness.

Reference is now made to FIGS. 3A to 3C, which illustrate preferredembodiments of the present invention, in order to solve these twopotential problems. In FIG. 3A, there is shown a device of the typedescribed in FIGS. 1 and FIGS. 2A-2I herein, and in co-pendingInternational Application No. PCT/Il2006/000925, passing though a lumen1, and having balloons 4A, 4B etc, separators 10A, 10B, etc, andpassages 3, for allowing flow of the inflating fluid between balloons.It is observed that although the separators 10A, 10B, etc., may bestiff, the intrinsic flexibility of the balloons 4A, 4B, etc., may causethe device to be too “floppy” to be easily inserted or easily propelled.Furthermore, in FIG. 3B, there is also shown how, by inflation of aproximal balloon 4A, the more distal balloons 4B, etc., tend to becompressed rather being pushed forward.

Reference is now made to FIG. 3C, which illustrates a first preferredembodiment to alleviate these problems and to provide more uniformpropagation of the device. In FIG. 3C, stiffening elements 9 areinserted into the device between the separator sections. The length ofthe stiffening elements 9 is selected so that when the device isuninflated, there is a row of solid segments along the length of thedevice, thus increasing stiffness and facilitating entry. As the deviceis inflated sequentially, this continuous row of solid segments isoperative to mechanically push the entire distal parts of the deviceforward as the proximal balloons inflate.

Although the device shown in FIGS. 3A to 3C is of the type whichincludes a central channel or a guidewire passing through the balloons,it is to be understood that this embodiment is equally applicable to adevice without such a central channel or guidewire, on condition thatsome means of positional support is provided for the stiffening elements9, to keep them aligned with each other.

Reference is now made to FIG. 4A, which illustrates another preferredembodiment, in which the stiff core of the separator/orifice element 20Ais axially extended such that in the deflated position, the distal endof the element 20A touches the proximal end of the separator/orificeelement 20B of the neighboring section. This solution improves theability of the device to be pushed over the guidewire without folding upthe balloons. The guidewire at the center of the orifices gives axialstability. FIG. 4B shows the device extending as the balloons areinflated. Special openings 23 allow non-stop flow even if the gap 3between the sequential orifices sections is closed. Additionally andalternatively, if the shape of the protrusion 25 is constructed suchthat its contact surface with the following orifice section is not flat,but has fluid release passages cut into its profile, such a constructionwill allow flow even when the protrusion 25 touches the followingorifice section.

Reference is now made to FIGS. 5A to 5C, which illustrate anotherpreferred embodiment in which the axial stability is guaranteed by aflexible spring 30D between the separator/orifice elements 30A, 30B,30C, operating in an accordion fashion. The spring has a limited solidlength in its closed position, and is extendible in the axial directionwith the stretching of the inflated balloons. The closed stance of thespring is shown in FIG. 5A. The open stance is shown in two differentviews in FIGS. 5B, which is a cross section of the device with spring,and in FIG. 5C, which is a side view. The well-defined closed length ofthe spring allows for axial stiffness and push-ability of the device,while not limiting axial extension of the balloons for propulsion.

Reference is now made to FIGS. 6A to 6B, which illustrate anotherpreferred embodiment similar to that of FIG. 5A but with the springreplaced by axially extendable trellis-like extendible elements, 40A,40B, 40C, 40D, which do not allow relative rotation betweenseparator/orifice elements 41A, 41B, 41C, which the spring embodimentsof FIGS. 5A to 5C do. The axially extendable elements may be designedwith a double trellis structure, as shown in elements 40A, 40B of FIG.6A or with a single extendible structure, as shown in elements 40C, 40Dof FIG. 6B, or with any other similar design allowing axial extension,limited compression and axial rotational stability.

Reference is now made to FIG. 7A, which illustrates another preferredembodiment for achieving the effect shown in FIGS. 4A and 4B. In FIG.7A, the separator/orifice elements 50A, 50B, etc., are constructed withextended inter-sliding end extensions, so as to create telescopic motionbetween the separator/orifice elements which give extended axialstability even without the need for a guidewire. The special openings51B, in the extensions allow unimpeded flow of fluid between thetelescopic sections, since they allow free flow of the fluid from thegap section 51C around the guidewire, from where the fluid is supplied,out into the balloon volume 51A for inflating the balloons 4. Theopenings 51B must be of such a size and spaced apart by such a distancethat regardless of the mutual position of the two sliding extensions,there will always be at least one set of openings aligned such that thefluid can pass from the gap section 51C to the balloon volume 51A.

Though the embodiments of FIGS. 7A-7B show a guidewire running axiallythrough the center of the device, it is to be understood that thisarrangement could equally be applicable for an embodiment with a channelrunning through the device. It is to be understood that this comment,and its reverse, is applicable for all of the embodiments shown in theapplication having axially running elements. Such elements can generallybe guide wires or channels, except of course in those embodiments whereone or the other is mandated by the intended use.

Reference is now made to FIGS. 8A to 8B, which illustrate anotherpreferred embodiment of the present invention, in which rings 62 ofsimilar cross sectional shape and size to that of the separator/orificeelements 60A, 60B, 60C are inserted into the balloons. Orifices 63within the body of the separator elements provide flow of inflationfluid between balloons. In the example shown in the embodiment of FIGS.8A to 8B, the balloons are of the annular type around the walls 5 of aninternal channel 6. The rings 62 are free to move axially inside theballoons. They provide axial stiffness when pushing the device, bothduring insertion or during propagation.

One of the main uses of the tip-propelled devices described in thisapplication is to propel an endoscope and/or therapeutic tools into abodily passageway. The endoscopic vision system is usually fixed to thetip of the device, while the optical/electrical connections and toolinsertion generally require a special “working channel”, which goes allthe way through the device from the rear to the tip. The goal of thedevice is to propel the working channel into the passageway, with thepayload and operating point at its front end. In the embodimentsdescribed so far, the device has generally been simply regarded as alocomotion device for pulling its trailing channel into the passageway,and any working channel has been considered as being simply attached tothe rear end of the device and pulled through. This pulling action inthe prior art devices, occurs when the set of balloons deflates, withthe distal balloon anchored at the furthermost point of the passageway,and the deflation pulling up the rear of the device with the workingchannel attached thereto.

According to further preferred embodiments of the present invention, theworking channel is connected to the distal end (tip) of the device andnot to the tail of the device. This arrangement endows the device withpropulsion dynamics having significant advantages over previouslydescribed tail attached embodiments, in that a stronger pulling force isobtained on the working channel. This pulling force does not depend onthe flexibility of the balloons during deflation, as in the previouslydescribed embodiments, but rather, arises from a pulling action,generated by positive pressure in the balloons during the inflationcycle. This is known as an inverted cycle device.

Reference is now made to FIGS. 9A to 9G, which illustrate the action ofa preferred embodiment of the present invention, using the improvedtraction arrangement described above, in which the working channel isattached to the tip of the device. In the embodiment shown in FIG. 9A,the working channel 81 is connected to the tip 83 of the device, and theend may preferably be secured with a cover 82. The gap between theworking channel 81 and the trailing outer pipe or sheath 86 maypreferably serve as a supply line of fluid for inflating the balloons.The gap between separator section 80 and working channel 81 maypreferably serve as the orifice for transfer of inflation fluid fromballoon to balloon and for delay of the inflation/deflation process. Thesame gap also allows for free sliding of separator sections 80A, 80B,80C over the working channel 81. At the very tip of the device 84,endoscopic surveillance can be conducted and/or therapeutic tools can beapplied to the inside of the passageway.

During the inflation phase, the balloons are sequentially inflated, asdescribed in FIG. 1 and FIGS. 2A-2I of this application, or as inco-pending International Patent Application No. PCT/Il2006/000925, or asin other sequential balloon embodiments described in other patents andarticles, and push the tip of the device forward. The tip thus pulls theworking channel which is connected to it. During the deflation phase,the outer pipe or sheath 86 is pulled forward by the deflation of theballoons 4A, 4B, 4C, etc., employing the natural elasticity of thematerial of the balloons, while the working channel is anchored at itsforward-most position.

A marker sign 85 is shown on the working channel in the drawings, toillustrate the propagation of the working channel forward with progressof the device through FIGS. 9B-9G. It should be noted that the mark hasbeen added only in the drawings to illustrate the progress of themotion, but that it is not meant to be a part of the device itself.

The advantage of propulsion using this arrangement is that thepotentially heavy, bulky working channel is pulled during the morepowerful inflation phase, where the internal supplied, positiveinflation pressure is used, rather than during the deflation phase whereonly the elastic properties of the balloon material relaxing provide thepropulsion force.

Reference is now made to FIGS. 10A to 10G, which illustrate the actionof another preferred embodiment of the present invention, similar toFIGS. 9A to 9G in that the working channel is connected directly to thetip 73 of the device. At the very tip of the device 74, endoscopicsurveillance can be conducted and/or therapeutic tools can be applied tothe inside of the passageway.

In the preferred embodiment of FIGS. 10A to 10G, the balloons 78A, 78B,78C, are annular in shape, such that an additional balloon wall 79Aseparates the balloon volume 78A from the working channel 71. The flowdelaying orifices 75 are now located inside the separator sections 70A,70B, 70C. The working channel is thus totally separated from the deviceinflation fluid, which is preferably supplied by means of a separate lowprofile supply pipe 76. The supply pipe 76 can therefore be made thinand flexible making the device tail lighter in weight than in theembodiment of FIGS. 9A to 9G where an outer sheath is used to supply theinflation fluid.

The advantage of the annular, double balloon system and the concomitantseparation of the inflating fluid from the working channel allows forsmoother operation, more precise orifice cross section, and extendedbending capabilities of the device. The friction between the workingchannel 71 and the inner balloon wall 79A should be small. A lubricantmaterial can be used to lower the friction and to allow for free slidingbetween them. The supply line 76 and working channel 71 may preferablybe enclosed by an outer sheath (not shown), which can be lightweight. Asin FIGS. 9A to 9G, a marker 5B is shown on the working channel toindicate the movement of the working channel at each successive ballooninflation.

In the preferred embodiments of FIGS. 9A to 9G, the working channel 81moves axially inside the separator/orifice sections 80A, 80B, 80C. Theworking channel 81 is connected to the tip and is therefore pulledforward. This means that the length of working channel should beindependent of the length of the supply line 86, since the workingchannel has a longer range of motion than the supply line.

Reference is now made to FIGS. 11A and 11B which illustrate preferredembodiments of a length compensation mechanism for achieving this lengthseparation, by means of a hermetically closed termination chamber 140.In FIG. 11A, there is shown the entry point 143 of the working channelat its normal length. The working channel is coiled up 141 in an arc.When the balloons are inflated, the working channel 141 is pulledforward to the position shown in FIG. 11B. The marker sign 146 shows themovement of a length of the working channel, which is the differencebetween the length of the inflated and deflated balloons of the device.The fluid for inflation of the balloons resides within the terminationbox 140 in the area 144 and flows freely between the working channel andthe outer supply line 149. The input connector 148 for the inflatingfluid can be placed anywhere in the box 140, such that it will applypressure to the volume of fluid 144. The dimension 147 marks the motionof the working channel for a single balloon inflation step.

Since pressure in a cylindrical balloon stretches the balloon skin andputs it under tension, inflated balloons connected by rigid separatorsections, as in the previously shown embodiments, resist any tendency ofthe device to bend, such as is required when negotiating curves in thelumen. In order to overcome this problem, a number of further preferredembodiments are shown in FIGS. 12A to 12C, which allow the device tobend by providing flexible separator sections between balloons 100A and100B. In the preferred embodiment of FIG. 12A, the separator/orificesection is separated into two parts 102, with a flexible pipe 103between the two sections to allow for the fluid flow. The wholeseparator/orifice section can be made of very flexible material, whileensuring that its flexibility is such that the fluid passage through theorifice is not blocked by the bending. A flexible sheath 108 preferablykeeps the gap between the balloons clear and provides free angularmotion between the balloons.

FIGS. 12B and 12C show a further embodiment of a flexible joint device,with the ability for variable joint stiffness. A joint pressurizing pipe104,105 is added to the device, running from the internal volume of oneseparator section to the next, without interfering with the fluidpressures needed for device propagation. If a pressurized fluid issupplied into the pipe 104, 105, pressure is increased within theinternal volume of the separator section. This separator section has aflexible outer covering 101, and when it is pressurized it straightensup and becomes stiffer. In such a way the stiffness of the joints can becontrolled from very flexible to very stiff, in accordance with theinternal pressure 106 supplied by the joint pressurizing pipe 104, 105.

Reference is now made to FIGS. 13A and 13B which illustrate anotherpreferred embodiment of the present invention, in which the supply line131 and/or working channel 133 are coiled up inside a storage unit 132mounted on the rear of the device, and are deployed during propulsion.The orifice 130 supplies the inflation fluid to the first balloon. FIG.13B shows the device after having moved forward, with part of thecontent of the storage unit 132 having been deployed. During suchoperation the device does not need to pull the supply line and/orworking channel, thus eliminating friction of the channel with the wallsof the passage being traversed.

Reference is now made to FIGS. 14A and 14B which illustrate anotherpreferred embodiment of the present invention, which enables the deviceto travel backwards out of the lumen, using a similar positivepropulsion mechanism to that described hereinabove for the forwardpropulsion. In the embodiment of FIG. 14A, an additional fluid supplyline 113 preferably passes through the length of the device, and isconnected to the distal balloon 112D at the tip. The fluid supplypreferably passes from segment to segment by means of an additionalorifice in the separator/orifice sections 111, with the separate supplyline 113 connecting the orifices. This embodiment requires two trailingfluid supply lines, one 115 connected by orifice 114 to the proximalballoon 112A for forward motion and one 116, connected to the distalballoon 112D through line 113 for the backward motion.

In the preferred embodiment of FIG. 14B, the device is supplied withonly one global fluid supply line 118, and a valve 117 switches thissupply either to the proximal balloon for forward motion or to thedistal balloon for backward motion. When the inflation starts from thedistal balloon, the sequence of inflation/deflation is reversed andbackward propulsion is attained in a manner similar to forwardprolusion.

There is an additional advantage of having control over the distalballoon inflation before that of the other balloons. When the device hasreached its functional position, and it is desired to perform itsintended procedure, it may be in a situation with all of the balloonsdeflated, such that the device is not anchored within the lumen. Inorder to effect such anchoring, using this embodiment, pressure can besupplied initially to the distal balloon, which may be the closest tothe working point, in order to keep it inflated and anchored to thelumen.

According to a further preferred embodiment of the present invention,two or more devices may be connected, pointing in opposite directions asshown in FIGS. 15 and 16A, each complete with its own supply line. Thisprovides the ability to use two single direction devices in oneoperative unit, which will have the ability to move in oppositedirections, depending on which supply line is used.

In FIG. 15, one supply line 194 feeds the balloons 192A-192C at thedistal end of the device, while line 195 feeds the balloons 191A-191C atthe proximal end of the device. Orifices 193 set in the separatingelements 190B-190F provide inter balloon connection in each set ofballoons. A sheath 196 preferably covers the trailing supply lines.

In FIG. 16A, the supply lines 205, 206 are attached to the two sets ofballoons 202A-C and 203A-C at their junction. The inflation fluid ispassed from balloon to balloon through orifices 201 in the separators200.

According to another embodiment of similar nature, both oppositelyfacing devices may have a common supply channel but activated bydifferent pressures, for example, by means of a pressure sensitive valve207 as shown in FIG. 16B, or, by selecting the size or thickness of theballoons of the two devices such that they will operate at differentpressures, or simply by means of a 2-way valve 207.

According to a further preferred embodiment of the present invention,the device is propelled to the end of the colon preferably whilescreening, recording and taking images, as is usual in colonoscopy. Incase a further treatment is required, such as removal of a polyp, atreatment device is pushed over the device tail (supply line), as ifover a guide-wire. While the therapeutic tool is being pushed on, thedevice is kept fully inflated to achieve anchoring to the end of thecolon.

According to a variation of this embodiment, the treatment device is notpushed but is self-propelled by using inwardly directed inflation, suchthat it crawls up the guidewire, as shown in the embodiment of FIGS. 12Aand 12B of the above mentioned PCT/Il2006/000925.

The last few centimeters of the colon may be problematic to treat sincethe inflated device is located there, preventing access for treatment.According to a further embodiment of methods of use of the presentinvention, the device is stopped short of the end of the colon, and thetreatment tool breaks through the tip of the working channel and hasaccess to the distal end. Full colon coverage is thus obtained for thetreatment tool

Pigtail insertion is a frequent surgical procedure, such as is performedin ureteral bypass. According to a further preferred embodiment of thepresent invention, the pigtail, which is a simple pipe—curled at theends, is equipped with a self-propelled device at one end. It willself-propel through the ureter and stay there, once disconnected fromsupply line. The principle applies not only for ureter bypass but forany applications requiring the placing of a bypass support. The supplychannel of the self-propelled device described in the above mentionedPCT/Il2006/000925 and in this application, can itself serve as bypassafter disconnecting from the main fluid supply line.

The device can be combination of several different sized devices, wherea smaller device will be used in the ureter, and the larger diameter onein the urethra. The two devices may preferably be inserted serially, andseparated when the ureteral device is in place.

A number of different embodiments are now given by which the devices ofthe present invention may be manufactured. Referring now to FIGS. 17A to17D, separator sections 160A, 160B, 160C are selectively covered by asoluble mask 161 at the regions where the balloons are to be formed, asshown in FIG. 17B. An alternative option is to cover all the outer areaof sections 160 and selectively dissolve a negative image.

The whole device is then covered by elastic material 162 by molding ordipping techniques or any other elastomer manufacturing techniques asshown in FIG. 17C.

Finally, the mask material 161 is dissolved by injecting a solventthrough channels 163 and the hollow balloons 164 are created as shown inFIG. 17D.

FIGS. 18A to 18D illustrate a further method of manufacture, wherein thehollow balloon area to be manufactured is made of a soluble material151, and then covered with an elastic material 153. The soluble materialis then dissolved through channels 152 and a hollow balloon 155 iscreated.

The soluble mask method can also be used for manufacturing annulardouble balloon systems, such as those described in FIG. 12 of theco-pending PCT/Il2006/000925. The procedure is shown in FIGS. 19A to19D. The cylinder core 172 between the separator sections 170 is madefrom soluble material. The whole assembly is coated by an elastomer 173inside and out, such as silicone or polyurethane. After curing thesoluble core 172 is dissolved 174, leaving only the separator elements170 with their orifices 175, and the annular balloon 173 over them. Thedouble balloon system is then created, as shown in FIG. 19D.

Reference is now made to FIGS. 20A to 20D, which illustrate anotherpreferred embodiment of the present invention, which enables the deviceto propagate in a flexible, slippery, or collapsible media. Use of thisembodiment maintains the balloons 90A, 90B in contact with the lumenwall 1 most of the time. This embodiment is particularly important, forexample, in colonoscopy, where the colon is normally in a collapsed andslippery configuration.

A flexible membrane 91 connects neighboring balloons 90A, 90B, as shownin FIG. 20A. The membrane 91 may have small openings 92. When theballoons are deflated as in FIG. 20A, the flexible lumen 1 is generallycollapsed onto the membrane 91, such that volumes 93 and 94 are closedvolumes.

When the two adjacent balloons 90A, 90B, become inflated, as in FIG.20B, the volumes 93 and 94 grow in volume but since they are closedvolumes the pressure drops and the lumen 1 is pulled towards themembrane 91. By this means, the device achieves more friction with thelumen 1 which assists when propagating in slippery surrounding.

The membrane may be radially segmented as shown in cross sectionalviews, FIGS. 20C and 20D, which assists traction if the contact with thelumen 1 is so shaped that it only partially contacts the membrane 91around its circumference. In such a case only some of the segments willbe closed, since only some of the holes 92 will be in contact with themembrane, and hence closed off. According to this segmentedconstruction, even if parts of the circumferential wall of the lumen donot touch the membrane 91, closure is still affected by other segments,and a good grip with the lumen wall is still ensured.

In a regular colonoscope, the CCD camera is preferably located at thetip. In this case the camera lens or front viewing window may becomedirty from being pushed through and collecting any waste material in thecolon. Furthermore, the colon wall is generally collapsed in its regularconfiguration, so that, in order to view the colon, the area underinspection should be inflated to open it up.

Reference is now made to FIGS. 21A and 21B, which illustrate anotherpreferred embodiment of the present invention, which enables the deviceto view the lumen inner wall without getting contaminated. The camera126 is located between two adjacent balloons, preferably close to thetip end, thus having a clear view of fully opened/stretched colon, asshow in FIG. 21A. In addition to the balloon inflation tube 120, achannel 121 may preferably be provided for carrying optic fibers orelectric leads for the optical or electronic camera. Channel 121 insidethe balloons is preferably flexible, and so does not interfere with thedevice propagation sequence. Channel 121 can also be located outside ofthe device. The camera can be located facing outwards or inside thecamera housing unit 125, and may be equipped with a light source—opticalor electrical, illuminating the field of view 127.

According to a further preferred embodiment, wall cleaning capabilitiesmay also preferably be mounted on the camera housing unit 125.

Reference is now made to FIG. 21B, which illustrates how the camerahousing unit 125 can also preferably incorporate a therapeutic,steerable exit channel 129, for performing simple surgical procedureswithin the lumen. The channel can be mounted separately or in the sameunit as the camera 126. The channel can have pitch, yaw and rollsteering capabilities. It can be used for different devices inserted forinspection and/or therapy.

Reference is now made to FIG. 22, which illustrates another preferredembodiment of the present invention, in which a wall cleaning unit islocated at the tip of the device, or between the balloons. Such anembodiment is useful in medical applications, such as colonoscopy orureteroscopy for debris or stone removal or for cleaning. In FIG. 22,the inflated balloons system opens up the area and floating particles orparticles 183 stuck to the lumen wall can be washed out by means of astream of cleaning fluid supplied by incoming and outgoing doublechannels 180. Active or passive washers 184 move or vibrate theparticles or fluids and they are washed out. The cleaning unit can befollowed by a camera unit, such as that shown in FIG. 21A, so that afterthe surrounding walls have been cleaned using the present embodiment,the camera unit 126 can record clear pictures.

Finally, it is to be emphasized that although the various embodiments ofFIGS. 3 to 22 have been generally described in relation to inflatableballoon devices where the inflation sequence is determined by thepassive flow of fluid from one balloon to its neighboring balloonthrough a predetermined orifice, it is to be understood that theimprovements and arrangements of these new embodiments can equally wellbe applied for use in inflatable balloon devices where the inflationsequence is generated by separate inflation lines, or by active controlof fluid flow valves, such as are described in some of the prior artdocuments cited in the Background section of this application. Theinvention is thus not meant to be limited to passive sequentiallyinflatable balloon devices, but to be applicable to any sequentiallyinflatable balloon devices.

It is appreciated by persons skilled in the art that the presentinvention is not limited by what has been particularly shown anddescribed hereinabove. Rather the scope of the present inventionincludes both combinations and subcombinations of various featuresdescribed hereinabove as well as variations and modifications theretowhich would occur to a person of skill in the art upon reading the abovedescription and which are not in the prior art.

We claim:
 1. A self-propelled device for locomotion through a lumen,comprising: two sets of serially arranged inflatable chambers, adjacentchambers of each set being connected by passages providing fluidcommunication between said adjacent chambers, each of said sets havingat least a distal and a proximal chamber, said sets being connectedserially; and a fluid supply system for inflating said chambers of eachof said sets sequentially by fluid flow through said passages betweenadjacent chambers; wherein said fluid supply system is connectable to aproximal chamber of one set and to a distal chamber of the other set,such that said device can move in either direction in accordance withwhich of said chambers is supplied with fluid.
 2. A self-propelleddevice according to claim 1 and wherein said fluid supply system isconnectable to said proximal and distal chambers by separate supplylines.
 3. A self-propelled device according to claim 1 and wherein saidfluid supply system is connectable to said proximal and distal chambersby means of a single supply line directed to one or the other of saidproximal and distal chambers by means of a valve.